Smartflow Catheter
FDA 510(k) K123605 · Mri Interventions, Inc.
510(k) numberK123605
Submission
- Device name
- Smartflow Catheter
- Applicant
- Mri Interventions, Inc.
Irvine, CA, US - Received
- November 21, 2012
- Decision date
- August 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K161731 | Cleveland Multiport Ventricular Catheter SetHCA · Traditional | Parker Hannifin Corp. | 03/27/2017SE |
| K031123 | Codman Bactiseal Barium Striped CathetersHCA · Special | Codman & Shurtleff, Inc. | 05/14/2003SE |
| K021481 | Bresagen Catheter, Model CS-3000HCA · Traditional | Bresagen, Inc. | 08/06/2002SE |
| K020728 | Miethke Shunt SystemHCA · Special | Aesculap, Inc. | 04/05/2002SE |
| K013005 | Act 11 MP Ventricular CatheterHCA · Traditional | Innerspace, Inc. | 03/08/2002SE |
| K003322 | Codman Bactiseal CathetersHCA · Traditional | Codman & Shurtleff, Inc. | 10/01/2001SE |
| K992796 | Aspiration/Irrigation Catheter, Model AC-1000HCA · Traditional | Image-Guided Neurologics, Inc. | 10/25/1999SE |
| K983331 | Medtronic PS Medical Innervision Ventricular Catheter, 15CM Model 99102HCA · Traditional | Medtronic PS Medical | 12/16/1998SE |
| K834477 | Dispos. Scott Cannulas 16-1054 Etc.HCA · Traditional | Codman & Shurtleff, Inc. | 03/19/1984SE |
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Questions and answers
When was Smartflow Catheter cleared by the FDA?
Smartflow Catheter (K123605) received a 510(k) decision of Substantially Equivalent on August 16, 2013, 268 days after the submission was received.
What is the product code of K123605?
The FDA product code is HCA – Catheter, Ventricular, a Class II (moderate risk) device regulated under 21 CFR 882.4100.